The push to push drugs on the American people is heavily dependent on the ability to produce favorable research that backs any and all claims that marketing departments wish to make about the drug in order for it to stand out in the competitive field of retail drug sales. Thanks to the admissions of some of the most influential people in this industry, we are now discovering that much of the research being presented in support of many new drugs, vaccines and procedures is fake, and even leading medical journals are agreeing that big pharma manipulates medical research at the expense of public health.Consider the following statements and admissions by very important people who are close enough to the inner workings of the industry to know for sure just how bad the public is being deceived.

In 2015, the editor of one of the world’s most respected medical journals, The Lancet, went public with his admission that research fraud was rampant in the field of medical clinical research:

The following clip is from the documentary ‘One More Girl,’ about the startlingly damaging effects of the Gardasil vaccine. In the clip, former Pfizer Vice President, Dr. Peter Rost candidly discusses the truth about the influence of money in the pharmaceutical industry. Dr. Rost wrote the book, The Whistleblower, Confessions of a Healthcare Hitmanto contribute to the growing body of evidence that blows the whistle on corporate fraud within the medical establishment.

Dependence on so-called clinical research to support the claims made by pharmaceutical marketing departments is proving to be dangerously misled. Can the public trust the medical establishment to bring effective and safe medicines to market? Increasingly, the evidence is suggesting that it is not.

Should you put your trust in medical research?

A review of more than 2,000 articles retracted by major biomedical journals revealed that more than two-thirds were retracted because of some type of fraud.

(Dag Sundberg, Getty Images)

Cory Franklin

Medical studies are on track to become the “reality television” of science.

A friend of mine, a physician with 30 years of experience in medical research who has published in the world’s top medical journals, recently said to me, “I don’t believe most of the studies published in the medical literature anymore.” His candid skepticism was because he feels medical researchers are losing the trust of the public.

Trust is an essential ingredient of medical research. The accelerating erosion of trust in the biomedical literature that my friend noted is the result of several factors: fraud, conflicts of interest, and inadequate scientific and journalistic peer review. These malign influences have corrupted scientific literature for generations, but their current manifestations are particularly acute in medical research.

Last month, fraud came to the fore when the prestigious journal Science retracted a prominent paper on gay marriage after the lead author lied about certain features of the study. This high-profile retraction was only the latest evidence that fraud has become depressingly common in the biomedical literature. A review of more than 2,000 articles retracted by major journals revealed that more than two-thirds were retracted because of some type of fraud. Moreover, the percentage of articles retracted because of fraud is roughly 10 times higher than it was in 1975.

While some of this may be because of greater scrutiny, an increase of that magnitude should not be ignored because the consequences of fraud in the medical literature can be devastating. Consider two examples: The current movement against vaccination for children stemmed — in large part — from a well-publicized but fraudulent 1998 paper in The Lancet. In another case, as many as 40,000 women were treated for breast cancer with bone marrow transplants in the 1990s at a cost of billions of dollars. This treatment was based on studies revealed to be fraudulent. Bone marrow transplant, effective for certain blood disorders, turned out to be not only relatively ineffective for breast cancer, but often dangerous.

The Independent: Another 18 girls claim adverse reactions to the HPV vaccine

Eighteen Irish teenage girls have recently come forward claiming to be suffering acute physical side-effects from the controversial HPV anti-cervical cancer vaccine administered in their schools. Parents came forward after the Sunday Independent revealed similar claims of suffering from 131 young women a weekend ago.

These new allegations have surfaced since a doctor in Denmark (where Gardasil is no longer used) linked some chronic symptoms to the vaccination. In Denmark, one in 500 girls display a range of side-effects, there are 143 Irish teenagers are now suffering debilitating health issues, and we know girls in the US are suffering as well. Because of this, expert petitions are underway in France and Spain to ban its use, and Japan has stopped recommending the vaccine all together.

How safe is the HPV vaccine? Thousands of adverse reactions to cervical cancer jab recorded annually

THOUSANDS of adverse reactions to the lifesaving cervical cancer jab are being recorded by health chiefs every year, The Sunday Post can reveal.

Campaigners last night said the vaccine should no longer be given to schoolgirls until more is found out about the side-effects of the Human Papilloma Virus (HPV) vaccine.

The Post’s figures show more than 6,000 suspected adverse reactions to the jab have been recorded across the UK since 2012, including 340 in Scotland.

However, campaigners claim this is just the tip of the iceberg as health chiefs estimate they only receive reports about 10% of all suspected adverse reactions, suggesting tens of thousands could have suffered similarly.

More than eight million HPV jabs have been given to girls aged 12 and 13 in the UK since 2008 and the vaccination programme is credited with saving 400 lives every year.

But pressure is growing for the authorities to get a better understanding of the side-effects as the figures obtained by The Post show one person south of the Border died this year as a result of a suspected adverse reaction to the HPV jab.

MSPs on Holyrood’s petitions committee agreed to ask SNP ministers for their view on campaigners’ calls to hold a roundtable discussion on the safety of the vaccine, involving medical and scientific experts from both sides of the debate.

Gardasil, a vaccine for the Human Papillomavirus (HPV), has been labeled as a controversial since it has been made available. Although beneficial in preventing cancer within the girls that receive the vaccine, the side effects that some are experiencing can be debilitating for many girls. Those side effects have many wondering if the drug is safe enough for human use.

Common side effects of being vaccinated with Gardasil include nausea, headaches, and even fainting at the time of the vaccination, or shortly after, according to the Independent. However, more extreme side effects are more serious and longer lasting, often times permanent. They include chronic fatigue, chronic regional pain syndrome, postural tachycardia syndrome, and fibromyalgia, according to Jesper Mehlsen of the Frederiksberg Hospital in Denmark.

Mehlsen was quick to point out that the conditions have not been proven to be caused by Gardasil, but there is a growing trend among girls that have received the vaccine and are experiencing the exact same conditions over time.

“We have noted a pattern of symptoms in a relatively large group of patients and that these symptoms seem to have a temporal association to the vaccination.”

[Photo by Russell Kirk/Merck & Co. via Getty Images]

Recently, 18 teenage girls came forward to report debilitating side effects after taking Gardasil, joining the growing number of teens across the world that have experienced harmful side effects after taking Gardasil. In Ireland, about 131 girls have been identified, and in Denmark, over 1,100 hundred girls suffer from Gardasil side effects, according to the Independent. The number of reported drastic side effects in America vary depending on the study that is read. However, reports of negative and debilitating side effects from around the world have led nearly 40 percent of American parents to not vaccinate their children from HPV.

The Healing Power of Germs?

Fears surrounding exposure to microbes are omnipresent, which is why it may come as a surprise to find research showing infection with certain “germs” confers significant health benefits.

We live in a day and age where germ theory has undergone a sort of apotheosis, assuming an almost Godlike power to affect and permeate every area of our lives with the fear of infection.

Not only are external institutions increasingly attaining the authority to force us to inject ourselves and children with preparations purported to defend us against germs, but even our inner thoughts are often infected uncontrollably with fears about exposure to them. Even the CDC has declared itself impotent against so-called “nightmare” bacteria, adding to the sense of powerlessness so many feel about their health destinies.

What makes this situation all the more surreal is the relatively recent discovery of the microbiome, namely, the 100 trillion viruses, bacteria, fungi, parasites, which outnumber our own cells 10-1, and which proves that we are more “germ” than “human,” and in many respects, would not be alive without them: e.g. about 8% of our genome is retroviral in origin, 90% of our immune system depends on bacteria in our gut. How, then, can these microorganisms be as deadly as we are told, while at the same time be responsible for making possible our life itself?

The cognitive dissonance generated by these diverging, if not diametrically opposed paradigms — “microbes as deadly” versus “microbes as essential to life” — is enough to drive the non-fluoridated mind a bit crazy. But so much is riding on belief in one narrative over another. If germs are not as deadly as we are told, how would we justify the 60+ vaccines in the childhood vaccination schedule, and the 250+ in the developmental pipeline? Clearly, there are biopolitical and economic motivations pushing the germ-centric ideology forward, even in the face of an accumulating body of contrary evidence.

A choice of being able to feed and clothe their families . . . or vaccinate?

I don’t know about you, but if that is a “choice” then so is blackmail.

Add this to the Victorian government’s law that all unvaccinated children must be banned from early childhood education and you will see that. for some governments in Australia, the idea of segregating children is a good thing. So much for the government’s commitment to Universal Access to Early Childhood Education?

CDC exposed as private corporation colluding with Big Pharma to defraud American taxpayers: see the evidence

Thursday, December 03, 2015 by: Ethan A. Huff, staff writer

(NaturalNews) The illusory notion that the federal regulatory agency known as the Centers for Disease Control and Prevention (CDC) is somehow a public entity working on behalf of the people to protect us all from disease is simply laughable.

The CDC, by definition, is a private corporation working on behalf of its stakeholders, which include key players in the pharmaceutical and vaccine industries that profit from the spread of disease, not from real prevention and cures.

D&B is a Fortune 500 company based in New Jersey that maintains databases on more than 235 million companies worldwide – it’s a who’s who of the global business climate, and is recognized as one of the first companies to be publicly traded on the New York Stock Exchange (NYSE).

Here’s a screenshot of the CDC’s listing on D&B, courtesy of the AntiCorruption Society:

Big Pharma and the CDC: one in the same

Anyone who tries to argue with you that the CDC is looking out for public safety as its first priority just needs to take a glance at D&B to see that the CDC is actually looking out for its own bottom line, and that of its corporate allies. Which brings us into our second piece of evidence that the CDC is a corrupt, drug-pandering sham – many of the CDC’s top health “experts” have ties to the pharmaceutical industry.

These two companies, as reported by The Guardian in 2010, paid off policymakers in multiple countries, including in the U.S. (at the CDC), to write the WHO’s guidelines for swine flu that pushed dangerous swine flu vaccines on millions of people globally. With the help of the CDC and other corrupt agencies, these pharmaceutical corporations pocketed billions of dollars.

“The tentacles of drug company influence are in all levels in the decision-making process,” stated Paul Flynn, a British Member of Parliament who spoke out against this racket as it was occurring.

CDC pushes fake science promoting deadly drugs, vaccines

The CDC has also been complicit in forging fake science to push other dangerous vaccines like the MMR jab for measles, mumps and rubella. Robert F. Kennedy Jr. blew the lid on this scandal that same year, outing now-shamed scientist Poul Thorsen for stealing $2 million in research money while covering up the link between MMR and autism, which the CDC ate right up in its quest to protect the reputation of MMR.

Top CDC scientist Dr. William Thompson has also since come forward as a whistleblower to expose the CDC for manipulating research findings that showed MMR causes autism at a disproportionately higher rate in young black boys compared to other children – though MMR causes autism in all types of children, this same research found.

About NaturalNews

The NaturalNews Network is a non-profit collection of public education websites covering topics that empower individuals to make positive changes in their health, environmental sensitivity, consumer choices and informed skepticism. The NaturalNews Network is owned and operated by Truth Publishing International, Ltd., a Taiwan corporation. It is not recognized as a 501(c)3 non-profit in the United States, but it operates without a profit incentive, and its key writer, Mike Adams, receives absolutely no payment for his time, articles or books other than reimbursement for items purchased in order to conduct product reviews.

The vast majority of our content is freely given away at no charge. We offer thousands of articles and dozens of downloadable reports and guides (like the Honest Food Guide) that are designed to educate and empower individuals, families and communities so that they may experience improved health, awareness and life fulfillment.

(NaturalNews) The results of a 2004 study by the U.S. Centers for Disease Control and Prevention (CDC) discovered a significant link between the MMR vaccine (measles, mumps and rubella) and autism in African American boys vaccinated under or around the age 36 months; however, if it weren’t for one whistleblower, you would not have been privy to any of this, because the evidence was deliberately covered up.

Dr. William Thompson, currently a senior scientist at the CDC, recently made a shocking admission that he and his colleagues specifically arranged a meeting to destroy important documents related to the study in an attempt to withhold information from the public regarding a link between the MMR vaccine and autism.

As first reported by Sharyl Attkisson, a former CBS News journalist turned independent investigative reporter, Dr. Thompson and the study co-authors “scheduled a meeting to destroy documents related to the study.

“The remaining four co-authors all met and brought a big garbage can into the meeting room, and reviewed and went through all the hardcopy documents that we had thought we should discard, and put them into a huge garbage can.”

“The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism.” – CDC Senior Science Dr. William Thompson

However, aware that destroying documents in this manner was both illegal and unethical, Dr. Thompson kept hard copies of all the documents that had been disposed of, as well as maintained all associated computer files.

After securing a whistleblower attorney, Dr. Thompson came forward with his admission, providing relevant documents in August 2014 to the office of Rep. Bill Posey (R-Florida), who presented details of the cover-up on the floor of the U.S. House of Representatives.

Posey, who maintains that he is “pro-vaccine,” read the following quote by Dr. Thompson on the House floor:

My primary job duties while working in the immunization safety branch from 2000 to 2006, were to later co-lead three major vaccine safety studies. The MADDSP, MMR autism cases control study was being carried out in response to the Wakefield-Lancet study that suggested an association between the MMR vaccine and an autism-like health outcome.

There were several major concerns among scientists and consumer advocates outside the CDC in the fall of 2000, regarding the execution of the Verstraeten Study. One of the important goals that was determined up front, in the spring of 2001, before any of these studies started, was to have all three protocols vetted outside the CDC prior to the start of the analyses so consumer advocates could not claim that we were presenting analyses that suited our own goals and biases.

We hypothesized that if we found statistically significant effects at either 18 or 36 month thresholds, we would conclude that vaccinating children early with MMR vaccine could lead to autism-like characteristics or features. We all met and finalized the study protocol and analysis plan. The goal was to not deviate from the analysis plan to avoid the debacle that occurred with the Verstraeten thimerosal study published in Pediatrics in 2003.

At the Sept 5th meeting we discussed in detail how to code race for both the sample and the birth certificate sample. At the bottom of table 7, it also shows that for the non-birth certificate sample, the adjusted race effect statistical significance was huge.

All the authors and I met and decided sometime between August and September 2002, not to report any race effects from the paper. Sometime soon after the meeting, we decided to exclude reporting any race effects.

The co-authors scheduled a meeting to destroy documents related to the study.

The remaining four co-authors all met and brought a big garbage can into the meeting room, and reviewed and went through all the hardcopy documents that we had thought we should discard, and put them into a huge garbage can.

However, because I assumed it was illegal and would violate both FOIA and DOJ requests, I kept hardcopies of all documents in my office, and I retain all associated computer files. I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper.

The CDC and Dr. Thompson’s co-author Dr. Frank DeStefano, CDC Director of Immunization Safety, continue to defend the study as originally published.

A July 29 Tweet by Attkisson states:

So far, no hearings scheduled and no known inquiry of the alleged scientific misconduct.

About NaturalNews

The NaturalNews Network is a non-profit collection of public education websites covering topics that empower individuals to make positive changes in their health, environmental sensitivity, consumer choices and informed skepticism. The NaturalNews Network is owned and operated by Truth Publishing International, Ltd., a Taiwan corporation. It is not recognized as a 501(c)3 non-profit in the United States, but it operates without a profit incentive, and its key writer, Mike Adams, receives absolutely no payment for his time, articles or books other than reimbursement for items purchased in order to conduct product reviews.

The vast majority of our content is freely given away at no charge. We offer thousands of articles and dozens of downloadable reports and guides (like the Honest Food Guide) that are designed to educate and empower individuals, families and communities so that they may experience improved health, awareness and life fulfillment.

Vaccinated Norwegians Get Mumps During “Outbreak”

Roughly 80 Norwegian college students have reportedly contracted mumps. Of the 80, many reportedly were previously vaccinated with the MMR vaccine, which, by all logical and reasonable accounts, should have protected them. However, Norwegian health officials are making excuses over the matter.

Mumps outbreak reported in Norway college students

The Norway Institute for Public Health, or Folkehelseinstituttet has announced a mumps outbreak, primarily among university students. The first reported cases were in the Trondheim area–the Norwegian technical and University of Science and Technology (NTNU) and the University College of Sør-Trøndelag (HIST) in late October.

Norway/CIA

Now the case count hovers around 80 and health officials expect the cases to increase in coming weeks.

Several of those who are now sick with mumps are Norwegian students who have previously received two doses of MMR vaccine is recommended.

It is possible to get sick with mumps even if you have been fully vaccinated against the disease, confirming Margrethe Greve-Isdahl, chief physician at the Department of vaccine, Public Health (FHI).

In Norway, the vaccine against mumps in the MMR vaccine (measles, mumps and rubella) offered in the childhood immunization. First dose offered to children at 15 months of age and second dose at 11 years of age (6th grade). FHI generally recommend that all who have not received two doses of MMR vaccine are eligible for this. This also applies to students who come to Norway. Upon initial vaccination is recommended that at least three months between doses, but there is a benefit to the immune response if it goes longer.

Why the United States Leaves Deadly Chemicals on the Market

November 21, 2015

By Valerie Brown and Elizabeth Grossman

Scientists are trained to express themselves rationally. They avoid personal attacks when they disagree. But some scientific arguments become so polarized that tempers fray. There may even be shouting.

Such is the current state of affairs between two camps of scientists: health effects researchers and regulatory toxicologists. Both groups study the effects of chemical exposures in humans. Both groups have publicly used terms like “irrelevant,” “arbitrary,” “unfounded” and “contrary to all accumulated physiological understanding” to describe the other’s work. Privately, the language becomes even harsher, with phrases such as “a pseudoscience,” “a religion” and “rigged.”

The rift centers around the best way to measure the health effects of chemical exposures. The regulatory toxicologists typically rely on computer simulations called “physiologically based pharmacokinetic” (PBPK) modeling. The health effects researchers—endocrinologists, developmental biologists and epidemiologists, among others—draw their conclusions from direct observations of how chemicals actually affect living things.

The debate may sound arcane, but the outcome could directly affect your health. It will shape how government agencies regulate chemicals for decades to come: how toxic waste sites are cleaned up, how pesticides are regulated, how workers are protected from toxic exposure and what chemicals are permitted in household items. Those decisions will profoundly affect public health: the rates at which we suffer cancer, diabetes, obesity, infertility, and neurological problems like attention disorders and lowered IQ.

The link from certain chemicals to these health effects is real. In a paper published earlier this year, a group of leading endocrinologists concluded with 99 percent certainty that environmental exposure to hormone-disrupting chemicals causes health problems. They estimate that this costs the European Union healthcare system about $175 billion a year.

Closer to home, Americans are routinely sickened by toxic chemicals whose health effects have been long known. To cite one infamous example, people exposed to the known carcinogen formaldehyde in FEMA trailers after Hurricane Katrina suffered headaches, nosebleeds and difficulty breathing. Dozens of cancer cases were later reported. Then there are workplace exposures, which federal government estimates link to as many as 20,000 cancer deaths a year and hundreds of thousands of illnesses.

Yet chemical regulation in the United States has proceeded at a glacial pace. And corporate profit is at the heart of the story.

That the chemical industry exerts political influence is well documented. What our investigation reveals is that, 30 years ago, corporate interests began to control not just the political process but the science itself. Industry not only funds research to cast doubt on known environmental health hazards; it has also shaped an entire field of science—regulatory toxicology—to downplay the risk of toxic chemicals.

Our investigation traces this web of influence to a group of scientists working for the Department of Defense (DOD) in the 1970s and 1980s—the pioneers of PBPK modeling. It quickly became clear that this type of modeling could be manipulated to minimize the appearance of chemical risk. PBPK methodology has subsequently been advanced by at least two generations of researchers—including many from the original DOD group—who move between industry, government agencies and industry-backed research groups, often with little or no transparency.

The result is that chemicals known to be harmful to human health remain largely unregulated in the United States—often with deadly results. For chemicals whose hazards are just now being recognized, such as the common plastics ingredient bisphenol A (BPA) and other , this lack of regulation is likely to continue unless the federal chemical review process becomes more transparent and relies less heavily on PBPK modeling.

Here we lay out the players, the dueling paradigms and the high-stakes health consequences of getting it wrong.

The dawn of PBPK simulation

The 1970s and 1980s saw a blizzard of environmental regulation. The Clean Air Act, Clean Water Act and Toxic Substances Control Act, along with the laws that established Superfund and Community Right-to-Know Programs, for the first time required companies— and military bases—using and producing chemicals to account for their environmental and health impacts. This meant greater demand for chemical risk assessments as the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) began to establish safety standards for workplace exposures and environmental cleanups.

In the 1980s, the now-defunct Toxic Hazards Research Unit at the Wright-Patterson Air Force Base in Dayton, Ohio, was investigating the toxicity and health effects of chemicals used by the military. Of particular concern to the DOD were the many compounds used by the military to build, service and maintain aircraft, vehicles and other machinery: fuels and fuel additives, solvents, coatings and adhesives. The military is responsible for about 900 of the approximately 1,300 currently listed Superfund sites, many of which have been contaminated by these chemicals for decades.

In the mid-1980s, scientists at the Wright-Patterson Toxic Hazards Research Unit began using PBPK simulations to track how chemicals move through the body. Known as in silico (in computers) models, these are an alternative to testing chemicals in vivo (in live animals) or in vitro (in a test tube). They allow scientists to estimate what concentrations of a chemical (or its breakdown products) end up in a particular organ or type of tissue, and how long they take to exit the body. The information can then be correlated with experimental data to set exposure limits—or not.

PBPK simulations made testing faster and cheaper, something attractive to both industry and regulators. But the PBPK model has drawbacks. “It tells you nothing about effects,” says Linda Birnbaum, director of both the National Institute of Environmental Health Sciences (NIEHS) and National Toxicology Program (NTP). Observational studies and laboratory experiments, on the other hand, are designed to discover how a chemical affects biological processes.

Even regulatory toxicologists who support PBPK acknowledge its limitations: “[PBPK models] are always going to be limited by the quality of the data that go into them,” says toxicologist James Lamb, who worked for the NTP and EPA in the 1980s and is now principal scientist at the consulting firm Exponent.

The late health effects researcher Louis Guillette, a professor at the Medical University of South Carolina famous for studies on DDT’s hormonedisrupting effects in Florida alligators, put it more bluntly: “PBPK? My immediate response: Junk in, junk out. The take-home is that most of the models [are] only as good as your understanding of the complexity of the system.”

Many biologists say PBPK-based risk assessments begin with assumptions that are too narrow, and thus often fail to fully capture how a chemical exposure can affect health. For example, a series of PBPK studies and reviews by toxicologist Justin Teeguarden of the Pacific Northwest National Laboratory in Richland, Wash., and his colleagues suggested that BPA breaks down into less harmful compounds and exits the body so rapidly that it is essentially harmless. Their research began with certain assumptions: that BPA only mimics estrogen weakly, that it affects only the body’s estrogen system, and that 90 percent of BPA exposure is through digestion of food and beverages. However, health effects research has shown that BPA mimics estrogen closely, can affect the body’s androgen and thyroid hormone systems, and can enter the body via pathways like the skin and the tissues of the mouth. When PBPK models fail to include this evidence, they tend to underestimate risk.

Because of its reliance on whatever data are included, PBPK modeling can be deliberately manipulated to produce desired outcomes. Or, as University of Notre Dame biologist Kristin Shrader-Frechette, who specializes in human health risk assessment, says: “Models can offer a means of avoiding the conclusions derived from actual experiments.” In other words, PBPK models can be customized to provide results that work to industry’s advantage.

That’s not to say PBPK itself is to blame. “Let’s not throw the baby out completely with the bathwater,” says New York University associate professor of environmental medicine and health policy Leo Trasande. “However, when you have biology telling you there are basic flaws in the model, that’s a compelling reason that it’s time for a paradigm shift.”

A handy tool for industry

That PBPK studies could be used to make chemicals appear safer was as clear in the 1980s as it is now. In a 1988 paper touting the new technique, Wright-Patterson scientists explained how their modeling had prompted the EPA to stop its regulation process for a chemical of great concern to the military: methylene chloride.

Methylene chloride is widely used as a solvent and as an ingredient in making plastics, pharmaceuticals, pesticides and other industrial products. By the 1990s, the U.S. military would be the country’s second greatest user. Methylene chloride was—and remains—regulated under the Clean Air Act as a hazardous air pollutant because of its carcinogenic and neurotoxic effects.

Between 1985 and 1986, the National Institute for Occupational Safety and Health estimated that about 1 million workers a year were exposed to methylene chloride, and the EPA classified the compound as a “probable human carcinogen.” A number of unions, including United Auto Workers and United Steelworkers, also petitioned OSHA to limit on-the-job exposure to methylene chloride.

In 1986, OSHA began the process of setting occupational exposure limits. Stakeholders were invited to submit public comments.

Among the materials submitted was a PBPK study by Melvin Andersen, Harvey Clewell—both then working at Wright-Patterson—and several other scientists, including two employed by methylene chloride product manufacturer Dow Chemical. Published in 1987, this study concluded, “Conventional risk analyses greatly overestimate the risk in humans exposed to low concentrations [of methylene chloride].”

Later that year, the EPA revised its previous health assessment of methylene chloride, citing the Wright-Patterson study to conclude that the chemical was nine times less risky than previously estimated. The EPA “has halted its rulemaking on methylene chloride [based on our studies],” wrote Wright-Patterson scientists in 1988.

OSHA, too, considered the Wright-Patterson study in its methylene chloride assessment—and its rulemaking dragged on another 10 years before the agency finally limited exposure to the chemical.

The usefulness of PBPK modeling to industry did not escape the Wright-Patterson researchers. “The potential impact,” wrote Andersen, Clewell and their colleagues in 1988, “is far reaching and not limited to methylene chloride.” Using PBPK models to set exposure limits could help avoid setting “excessively conservative”—i.e., protective— limits that could lead to “unnecessary expensive controls” and place “constraints on important industrial processes.” In other words, PBPK models could be used to set less-stringent environmental and health standards, and save industry money.

So far, they’ve been proven right. The work done at Wright-Patterson set the stage for the next 30-plus years. Results obtained using PBPK modeling—especially in industry-funded research, often conducted by former Wright-Patterson scientists—have downplayed the risk and delayed the regulation of numerous widely used and commercially lucrative chemicals. These include formaldehyde, styrene, tricholorethylene, BPA and the pesticide chlorpyrifos. For many such chemicals, PBPK studies contradict what actual biological experiments conclude. Regulators often defer to the PBPK studies anyway.

A web of influence

At the time that PBPK modelling was being developed, the chemical industry was struggling with its public image. The Bhopal, India, disaster—the methyl isocyanate release that killed and injured thousands—happened in 1984. The following year, a toxic gas release at a West Virginia Union Carbide plant sent about 135 people to hospitals.

In response to these incidents, new federal regulations required companies to account for the storage, use and release of hazardous chemicals. The minutes from a May 1988 Chemical Manufacturers Association (CMA) meeting show industry was feeling the pressure. Noting the federal scrutiny and the growing testing requirements, the CMA recommended that industry help “develop exposure data” and “explore innovative ways to limit required testing to that which is needed.”

Industry had already begun to do this by founding a number of research institutes such as the Chemical Industry Institute of Toxicology (CIIT), a nonprofit toxicology research institute (renamed the Hamner Institutes in an act of linguistic detoxification in 2007). This period also saw the rise of for-profit consulting firms like Environ (1982), Gradient (1985), ChemRisk (1985) and K.S. Crump and Company (1986), with which industry would collaborate advantageously in the following decades.

“Our goal was to do the science that would help the EPA and other regulatory bodies make the policies,” explained William Greenlee, Hamner president and CEO, in an interview for a business website. Indeed, over the past 30 years, Hamner and these consultancies have produced hundreds of PBPK studies, often with the support of chemical companies or trade groups. Overwhelmingly, these studies downplay or cast doubt on chemicals’ health effects—and delay regulation.

“I have seen how scientists from the Hamner Institutes can present information in a way that carefully shapes or controls a narrative,” says Laura Vandenberg, an assistant professor of environmental health sciences at University of Massachusetts Amherst. She explains that Hamner scientists often use narrow time windows or present data in a limited context, rejecting information that does not conform to their models. “These are the kinds of tactics used to manufacture doubt,” she says.

A close look at the authors of studies produced by these industry-linked research groups reveals a web of influence traceable to Wright-Patterson (see chart on following page). At least 10 researchers employed at or contracted by Wright-Patterson in the 1980s went on to careers in toxicology at CIIT/Hamner, for-profit consulting firms or the EPA. About half have held senior positions at Hamner, including the co-authors of many of the early Wright-Patterson PBPK studies: Melvin Anderson, now a chief scientific officer at Hamner, and Harvey Clewell, now a senior investigator at Hamner and principal scientist at the consulting firm ENVIRON. “I’m probably given credit as the person who brought PBPK into toxicology and risk assessment,” Andersen told In These Times.

A revolving door between these industry-affiliated groups and federal regulators was also set in motion. More than a dozen researchers have moved from the EPA to these for-profit consultancies; a similar number have gone in the other direction, ending up at the EPA or other federal agencies.

Further blurring the public-private line, CIIT/Hamner has received millions of dollars in both industry and taxpayer money. The group stated on its website in 2007 that $18 million of its $21.5 million annual operating budget came from the “chemical and pharmaceutical industry.” Information about its corporate funders is no longer detailed there, but Hamner has previously listed as clients and supporters the American Chemistry Council (formerly the CMA, and one of the most powerful lobbyists against chemical regulation), American Petroleum Institute, BASF, Bayer CropScience, Dow, ExxonMobil, Chevron and the Formaldehyde Council. At the same time, over the past 30 years, CIIT/Hamner has received nearly $160 million in grants and contracts from the EPA, DOD and Department of Health and Human Services. In sum, since the 1980s, these federal agencies have awarded hundreds of millions of dollars to industry-affiliated research institutes like Hamner.

But the federal reliance on industry-linked researchers extends further. Since 2000, the EPA has signed a number of cooperative research agreements with the ACC and CIIT/ Hamner. All involve chemical toxicity research that includes PBPK modeling. And in 2014, Hamner outlined additional research it will be conducting for the EPA’s next generation of chemical testing—the ToxCast and Tox21 programs. Over the past five years, Hamner has received funding for this same research from the ACC and Dow.

Meanwhile, the EPA regularly contracts with for-profit consultancies to perform risk assessments, assemble peer review panels and select the scientific literature used in chemical evaluations. This gives these private organizations considerable sway in the decision-making process, often with little transparency about ties to chemical manufacturers. The upshot: Experts selected to oversee chemical regulation often overrepresent the industry perspective.

These cozy relationships have not gone unnoticed; the EPA has been called to task by both its own Office of Inspector General and by the U.S. Government Accountability Office. “These arrangements have raised concerns that ACC or its members could potentially influence, or appear to influence, the scientific results that may be used to make future regulatory decisions,” wrote the GAO in a 2005 report.

Asked for comment by In These Times, the EPA said these arrangements do not present conflicts of interest.

Decades of deadly delay

PBPK studies have stalled the regulation of numerous chemicals. In each case, narrowly focused models developed by industry-supported research concluded that risks were lower than previously estimated or were not of concern at likely exposure levels.

Take, for example, methylene chloride, the subject of the 1987 paper Wright-Patterson scientists bragged had halted the EPA’s regulatory process. Despite the chemical being identified as “probably carcinogenic to humans” by the U.N. International Agency for Research on Cancer, a “reasonably anticipated” human carcinogen by the U.S. National Toxicology Program, and an “occupational carcinogen” by OSHA, the EPA has yet to limit its use. EPA researchers noted this year that the 1987 PBPK model by the Wright-Patterson scientists remains the basis for the agency’s risk assessment.

Today, methylene chloride remains in use—to produce electronics, pesticides, plastics and synthetic fabrics, and in paint and varnish strippers. The Consumer Product Safety Commission, OSHA and NIOSH have issued health warnings, and the FDA bars methylene chloride from cosmetics— but no U.S. agency has totally banned the chemical. The EPA estimates that some 230,000 workers are exposed directly each year. According to OSHA, between 2000 and 2012, at least 14 people died in the United States of asphyxiation or heart failure after using methylene chloride-containing products to refinish bathtubs. The Center for Public Integrity reports that methylene chloride exposure prompted more than 2,700 calls to U.S. poison control centers between 2008 and 2013.

Another telling example of industry-funded PBPK studies’ influence is formaldehyde. This chemical remains largely unrestricted in the United States, despite being a well-recognized respiratory and neurological toxicant linked to nasal cancer and leukemia, as well as to allergic reactions and skin irritation. The EPA’s toxicological review of formaldehyde, begun in 1990, remains incomplete, in no small part because of delays prompted by the introduction of studies—including PBPK models conducted by CIIT/Hamner—questioning its link to leukemia.

If that link is considered weak or uncertain, that means formaldehyde—or the companies that employ the sickened workers—won’t be held responsible for the disease. The chemical industry is well aware that “more people have leukemia … than have nasal tumors,” says recently retired NIEHS toxicologist James Huff.

Some of this CIIT/Hamner research was conducted between 2000 and 2005 with funding from an $18,750,000 EPA grant. In 2010, Hamner received $5 million from Dow, a formaldehydeproduct manufacturer, for toxicity testing, including PBPK modeling. The ACC, which opposes formaldehyde restriction, also supported this research.

Consequently, apart from a few state regulations and a pending EPA proposal to limit formaldehyde emissions from composite wood products like plywood, companies can still use the chemical—as in the FEMA trailers.

Cosmetics and personal-care products can also be sources of formaldehyde exposure. This made headlines in 2011 after hair salon workers using a smoothing product called Brazilian Blowout reported nausea, sore throats, rashes, chronic sinus infections, asthma-like symptoms, bloody noses, dizziness and other neurological effects. “You can’t see it … but you feel it in your eyes and it gives you a high,” salon owner and hair stylist Cortney Tanner tells In These Times. “They don’t teach this stuff in beauty school,” she says, and no one warns stylists about these products or even suggests using a ventilator.

OSHA has issued a hazard alert for these products and the FDA has issued multiple warnings, most recently in September, but regulations prevent federal agencies from pulling the products from store shelves. So, for formaldehyde, as in the case of the paint strippers containing methylene chloride, exposures continue.

BPA rings alarm bells

The chemical currently at the center of the most heated debates about consumer exposure is BPA. The building block of polycarbonate plastics, BPA is used in countless products, including the resins that line food cans and coat the thermal receipt paper at cash registers and ATMs. While scientific evidence of adverse health effects from environmentally typical levels of BPA mounts, and many manufacturers and retailers have responded to public concern by changing their products, federal regulatory authorities still resist restricting the chemical’s use.

BPA does not produce immediate, acute effects, like those experienced by salon workers exposed to formaldehyde or machinists working with methylene chloride. But in laboratory tests on animals, BPA is a known endocrine disruptor. Structurally similar to natural hormones, endocrine disruptors can interfere with normal cellular processes and trigger abnormal biochemical responses. These can prompt numerous health problems, including cancer, infertility, and metabolic and neurological disorders. BPA has also been linked to increased risk of cardiovascular disease, diabetes and obesity.

To promote the idea that BPA is safe, the chemical industry routinely lobbies policymakers and “educates” consumers. What has not been widely discussed, however, is how industry has backed PBPK studies that marginalized research showing risks from environmentally typical levels of BPA. Many of these doubt-inducing studies have been conducted by researchers whose careers can be linked to the PBPK work done at Wright-Patterson. In published critiques, health effects researchers—among them Gail Prins and Wade Welshons—have detailed the many ways in which these PBPK models fail to accurately reflect BPA exposure.

PBPK and endocrine disruption

Over the past several decades, our evolving understanding of our bodies’ responses to chemicals has challenged previous toxicological assumptions— including those that are fed into PBPK models. This is particularly true of endocrine disruptors.

Cause-and-effect relationships between endocrine disruptors and health problems can be hard to pinpoint. We now know that early—even prenatal— exposure to endocrine disruptors can set the stage for adult disease. In addition, a pregnant woman’s exposures may affect not only her children but also her grandchildren. These transgenerational effects have been documented in animal experiments. The classic human evidence came from victims of DES, a drug prescribed in the 1940s, 1950s and 1960s to prevent miscarriages. Daughters of women who took the endocrine disruptor developed reproductive cancers, and preliminary research suggests their daughters may be at greater risk for cancer and other reproductive problems.

“The transgenerational work raises an incredible specter,” says Andrea Gore, who holds the Vacek Chair in Pharmacology at the University of Texas at Austin and edits the influential journal Endocrinology. “It’s not just what you’re exposed to now, it’s what your ancestors were exposed to.”

Complicating PBPK modeling further, hormone-mimicking chemicals, just like hormones, can have biological effects at concentrations as low as parts per trillion. In addition, environmental exposures most often occur as mixtures, rather than in isolation. And each individual may respond differently.

“PBPK doesn’t come close” to capturing the reality of endocrine disruption, the late developmental biologist Louis Guillette told In These Times, in part because modelers are “still asking questions about one chemical exposure with one route of exposure.” Even for health effects researchers, understanding of mixtures’ effects is in its infancy.

The debate over how endocrine disruption can be represented in PBPK models has intensified the unease between regulatory toxicologists and health effects researchers. That tension is particularly well-illustrated by a recent series of events that also reveal how some journal editors privilege the industry’s point of view.

A life-and-death debate

In February 2012 the World Health Organization (WHO) and the U.N. Environment Programme (UNEP) published a report intended to inform regulation worldwide. The authors were an international group of health effects researchers with long experience studying endocrine disruption.

“There is an increasing burden of disease across the globe in which [endocrine disruptors] are likely playing an important role, and future generations may also be affected,” said the report. These diseases, it continued, are being seen in humans and wildlife, and include male and female reproductive disorders, changes in the numbers of male and female babies born, thyroid and adrenal gland disorders, hormone-related cancers and neurodevelopmental diseases.

The backlash from toxicologists was immediate. Over the next few months—as the EU prepared to begin its regulatory decision-making on endocrine disruptors—the editors of 14 toxicology journals each published an identical commentary harshly criticizing the WHO/UNEP conclusions.

The commentary included a letter from more than 70 toxicologists urging the EU not to adopt the endocrine disruption framework. The letter said that the WHO/UNEP report could not be allowed to inform policy because its science is “contrary to all accumulated physiological understanding.”

This commentary was followed by further attacks. One critique, published in the journal Critical Reviews in Toxicology, was funded and vetted by the ACC.

The dismissive approach to endocrine disruption science put forth … is unfounded, as it is [not] based on the fundamental principles of how the endocrine system works and how chemicals can interfere with its normal function.

Endocrinology editor Andrea Gore tells In These Times that she and other health effects researchers don’t think the scientifically demonstrated dangers of endocrine disruptors are subject to debate. “There are fundamental differences between regulatory toxicologists and what I refer to as ‘people who understand the endocrine science.’ ”

The outcome of this debate and the structure of future regulatory toxicity testing in the United States and Europe is not yet clear. The EPA appears to be attempting to incorporate endocrine disruption into PBPK models, but many scientists are skeptical the process will produce reliable results, given the models’ limitations and the complexity of endocrine effects.

From science to activism

Although couched in complex language, these arguments are not academic, but have profound implications for public health. Disorders and diseases, increasingly linked to exposure to endocrine disruptors— including metabolic, reproductive, developmental and neurological problems—are widespread and increasing. About 20 percent of U.S. adults show at least three of the five indicators of metabolic syndrome: obesity, diabetes, high blood pressure, high cholesterol and heart disease. Neurological problems, including behavioral and learning disabilities in children as well as Parkinson’s disease, are increasing rapidly. Fertility rates in both men and women are declining. Globally, the average sperm count has dropped 50 percent in the last 50 years.

Scientists typically shy away from activism, but many now believe it’s what’s needed to punch through the machinations and inertia regarding chemical regulation. Shanna Swan, Mount Sinai professor of preventive medicine, obstetrics, gynecology and reproductive medicine, notes that some of the biggest reductions in chemical exposures have happened in response to consumer pressure on both industry and policymakers. Or, as the University of California’s Bruce Blumberg says, “I think we need to take the fight to the people.”

The Endocrine Society stressed the urgency of addressing these public health impacts in a statement released September 28. Not surprisingly, industry disagreed, calling this science “unsupported” and “still-unproven.”

Meanwhile, PBPK studies continue to succeed in sowing doubt about adverse health effects of endocrine disorders. Their extremely narrow focus leads to narrow conclusions that often result in calls for more research before regulation. In regulatory decisions, “the assumption is that if we don’t know something, it won’t hurt us,” says University of Massachusetts, Amherst professor of biology R. Thomas Zoeller. In other words, the burden of proof remains on health effects researchers to prove harm, not on industry to prove safety—and proving harm is difficult, especially when other scientists are seeding doubt.

But the clock is ticking. As Washington State University geneticist Pat Hunt told In These Times, “If we wait [to make regulatory decisions] for ‘proof’ in the form of compelling human data, it may be too late for us as a species.”

This investigation was supported by the Leonard C. Goodman Institute for Investigative Reporting and published originally in In These Times.

Following is a public comment made by Barbara Loe Fisher, NVIC Co-founder & President, at the Nov. 13, 2015 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy

Birth defects, chromosomal damage, premature birth, low birth weight, pregnancy complications and sudden infant death syndrome, not infectious diseases, are the leading causes of death for about 23,000 infants dying before their first birthday in the US every year, with half of those deaths occurring on the first day of life. 1 2 Women getting pregnant and delivering babies in America today have more than twice the risk of dying during pregnancy, childbirth or within one year of giving birth than they did three decades ago, with heart failure, high blood pressure and stroke, diabetes, and blood clots being among the leading causes of death. 3 4

In 2006, CDC officials directed doctors to give all pregnant women a flu shot 5 and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. 6 Prior to FDA licensure, influenza, diphtheria, tetanus and pertussis vaccines were not tested in or proven safe and effective for pregnant women in large clinical trials when given during every pregnancy either singly or simultaneously. 7 8

Categorized by FDA as Pregnancy Category B and C biologicals 9 because it is not known whether the vaccines are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction, administering influenza and Tdap vaccines to pregnant women is an off-label use of these vaccines. 10 11 12 It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it. 13

The Return of Whooping Cough in High Vaccination Areas

Pertussis (whooping cough) has re-emerged in countries with high vaccination coverage and low mortality. Although it is listed as one of the top causes of vaccine preventable deaths, reports of a global resurgence originated in countries with low mortality and high vaccination coverage. Priorities are to decrease infant mortality by improving coverage and timeliness of vaccination and implementing pertussis surveillance, but vaccinations don’t seem to be working and this is of great concern.

More recently some countries with sustained high vaccine coverage have experienced increases in pertussis, especially in older children and adults, the reasons for which are complex. The issue may stem from under diagnosis or missed diagnosis and under-reporting, which hinder surveillance, as well as gaps in our knowledge of levels of herd immunity generated by the vaccination programs.Whooping cough is a relatively new infectious disease afflicting human beings, compared with other infectious diseases, and is undergoing a resurgence despite decades of vaccination.

One study found that the body’s response to a pertussis infection was correlated with vaccination status. There was a primary response in unvaccinated children.

Another study in the Center For Infectious Disease Dynamics showed that pertussis vaccination actually enhances the colonization Bordetella parapertussis, the bacteria that causes pertussis, and that the vaccination itself may have contributed to the observed increase in whooping cough over the last decade.

How common is whooping cough in a non-vaccinating country?

In Sweden, general vaccination with a whole cell pertussis vaccine was recommended from 1953. In 1979 the recommendation was withdrawn because the Swedish-made vaccine had become ineffective. In order to determine the incidence of the disease in a non-vaccinating country, 400 children born in 1980 were randomly selected from the population register of Goteborg, Sweden. The parents of the children were interviewed in 1990, when the children were 10 years old. The parents of 377 children could be reached, and of those 372 were not vaccinated against pertussis. Of the nonvaccinated children 61% had experienced clinically typical whooping cough; 195 (119 with and 76 without a history of whooping cough) agreed to donate a serum sample for determination of antibodies against pertussis toxin, filamentous hemagglutinin and pertactin. Of the children with a history of whooping cough, 91% had antibodies against pertussis toxin, as had 64% of the children without a history of disease. All but 3 children had antibodies against filamentous hemagglutinin and all 195 children had antibodies against pertactin. The antibody titers against the 2 last mentioned proteins did not differ between children with and without a history of whooping cough or between children with and without antibodies against pertussis toxin.

In light of the solid Swedish study why is the rest of the world still heavily vaccinating its citizens for whooping cough / pertussis when it has proven unsuccessful and appears to be increasing in the vaccinated groups? Could this enzyme deficiency in vaccinated subjects be linked to a lack of naturally occurring anti-bodies? From the time we are born our body’s immune system begins to create anti-bodies and depending on the region of birth they create anti-bodies specifically to the threats of their own community. In the western world we heavily vaccine children beginning at childbirth, is this resurgence of pertussis the result of not having their own antibodies due to a life time of vaccinations, this avenue of thought must be considered regardless of the outcome or the profits lost in the world wide vaccination programs?

It used to be that infants were not vaccinated as early as today they allowed 6 months for the child’s own immune defense to develop now they are vaccinated before leaving the hospitals. How can the individuals immune system develop if they are being shut down or altered with vaccinations, how can they hope to adapt to new virus protection when bacteria begin mutating? Do you think what is done in a laboratory is more efficient than what is done within the body pertaining to the individual needs and region to where they live? Will we look back at this generation and see the errors of our ways when antibiotics fail or will we line up for vaccinations each time a new strain of bacteria is discovered since we no longer have our own immune defense? This is an age of discovery but the question that remains unanswered is what the discovery will be?

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